Adding Ebola to the FDA Priority Review Voucher Program Act

Adding Ebola to the FDA Priority Review Voucher Program Act - Amends the Federal Food, Drug, and Cosmetic Act to add filoviruses, a family of viruses that includes the Ebola virus, to the list of tropical diseases under the priority review voucher program, which awards vouchers to sponsors of human drug applications that are approved to prevent or treat tropical diseases. (A voucher entitles the holder to have a future human drug application acted upon by the Food and Drug Administration (FDA) within six months.)

Changes the process by which infectious diseases that do not significantly impact developed nations and disproportionately affect poor and marginalized populations can be designated as tropical diseases from rulemaking to order of the Secretary of Health and Human Services (HHS).

Allows priority review vouchers to be transferred between sponsors of human drug applications any number of times.

Reduces from 365 days to 90 days the advance notice required before submitting a human drug application subject to a priority review voucher.

[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5729 Introduced in House (IH)]

113th CONGRESS
  2d Session
                                H. R. 5729

 To expand the program of priority review to encourage treatments for 
                           tropical diseases.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           November 18, 2014

Mrs. Blackburn (for herself, Mr. Gene Green of Texas, Mr. Butterfield, 
 Mr. McCaul, and Mr. Fleischmann) introduced the following bill; which 
          was referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
 To expand the program of priority review to encourage treatments for 
                           tropical diseases.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Adding Ebola to the FDA Priority 
Review Voucher Program Act''.

SEC. 2. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR TROPICAL DISEASES.

    Section 524 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360n) is amended--
            (1) in subsection (a)(3)--
                    (A) by redesignating subparagraph (Q) as 
                subparagraph (R);
                    (B) by inserting after subparagraph (P) the 
                following:
                    ``(Q) Filoviruses.''; and
                    (C) in subparagraph (R), as so redesignated, by 
                striking ``regulation by'' and inserting ``order of''; 
                and
            (2) in subsection (b)--
                    (A) in paragraph (2), by adding ``There is no limit 
                on the number of times a priority review voucher may be 
                transferred before such voucher is used.'' after the 
                period at the end; and
                    (B) in paragraph (4), by striking ``365 days'' and 
                inserting ``90 days''.
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